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AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure
The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.
Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
St. Vincent Birmingham & St. Vincent East
Birmingham, Alabama, United States
University of Alabama in Birmingham
Birmingham, Alabama, United States
Jacksonville Center for Research
Jacksonville, Florida, United States
Moffit Cancer Center
Tampa, Florida, United States
WellStar Research Institute
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Mass General Hospital
Boston, Massachusetts, United States
Start Date
June 1, 2011
Primary Completion Date
February 1, 2016
Completion Date
February 1, 2016
Last Updated
July 15, 2021
444
ACTUAL participants
Control
OTHER
ProGEL Pleural Air Leak Sealant with standard surgical closure
DEVICE
ProGEL Pleural Air Leak Sealant without standard surgical closure
DEVICE
Lead Sponsor
C. R. Bard
NCT06498635
NCT06066138
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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